Bevacizumab and Pembrolizumab Combination in EBER-ISH Positive NPC (2018/00947)
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|ClinicalTrials.gov Identifier: NCT03813394|
Recruitment Status : Not yet recruiting
First Posted : January 23, 2019
Last Update Posted : April 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Locally Recurrent Cancer Metastatic Nasopharyngeal Cancer||Drug: pembrolizumab Drug: bevacizumab||Phase 1 Phase 2|
The study will consist of 2 treatment arms. In Treatment Arm A, patients will be treated with intravenous pembrolizumab alone, 21-day cycle. For Treatment Arm B, patients will receive intravenous pembrolizumab preceded by an infusion of bevacizumab (Day 1 of 21-day cycle). Each treatment cycle is 3 weeks. Up to 48 patients will be enrolled in this study in 2 stages. The first stage will consist of 30 patients and the remaining 18 patients will be added if interim data looks promising.
Eligible patients will be randomized 1:1 into either Treatment Arm A or Arm B. Treatment will continue until tumor progression, intolerance to treatment, or up to 2 years (32 doses of pembrolizumab/bevacizumab). For patients who have progressed on pembrolizumab alone, cross over to Arm B is allowed, with repeat biopsy of the lesions before and 1 week after starting bevacizumab. Patients who discontinue from the trial will not be replaced.
The study will collect serial samples of tumor tissue and blood to determine the PD biomarkers of immune activation, in the tumor and systemically, following treatment. This is expected to provide preliminary evidence for immune stimulation using both pembrolizumab and bevacizumab in NPC. The tumor biopsies will also present an opportunity to determine the molecular details of tissue and tumor response to anti-angiogenic therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Eligible patients will be randomized 1:1 into either Treatment Arm A or Arm B. Treatment will continue until tumor progression, intolerance to treatment, or up to 2 years (32 doses of pembrolizumab/bevacizumab). For patients who have progressed on pembrolizumab alone, cross over to Arm B is allowed, with repeat biopsy of the lesions before and 1 week after starting bevacizumab. Patients who discontinue from the trial will not be replaced.|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib/II Open-label Study Evaluating the Combination of Bevacizumab Priming With Pembrolizumab in EBER-ISH Positive Nasopharyngeal Carcinoma (NPC)|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||March 1, 2023|
|Estimated Study Completion Date :||March 1, 2024|
Experimental: Treatment Arm A
Intravenous pembrolizumab alone,D8 of 21-day cycle.
-Pembrolizumab in Solution for Injection
Experimental: Treatment Arm B
Intravenous pembrolizumab preceded by an infusion of bevacizumab (Day 1 of 21-day cycle).
-Pembrolizumab in Solution for Injection
- Primary endpoint of ORR [ Time Frame: 2 years ]Comparison of the two treatment arms will be evaluated using the Fisher's exact test. The treatment effect will be quantified via the relative risk estimate and its associated 95% confidence interval (CI).
- The secondary endpoint of PFS [ Time Frame: 2 years ]This will be summarized using the Kaplan-Meier survival estimate for each group. As an exploratory analysis, the log-rank test will be used for comparing differences in PFS, with its effect quantified based on hazard ratio and its 95% CI.
- Progression free survival (PFS) [ Time Frame: 2 years ]This is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded central imaging assessment or death due to any cause, whichever occurs earlier.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813394
|Contact: Boon Cher Goh||(65) 6779 email@example.com|
|National University Hospital|
|Principal Investigator:||Boon Cher Goh||National University Hospital, Singapore|